A Single Arm Trial to Evaluate the Efficacy of Etanercept in Moderate to Severe Rheumatoid Arthritis Patients Who Failed to Respond or Lost a Satisfactory Response to Treatment With Adalimumab When Used as Their First Biologic Agent
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12
研究概览
简要总结
To evaluate the efficacy of etanercept in adults with moderate-to-severe rheumatoid arthritis (RA) who did not respond to or lost a satisfactory response to adalimumab when used as their first biologic agent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent
- •Diagnosed with moderate to severe rheumatoid arthritis for at least 6 months
- •Active RA with at least 3 swollen and tender joints
- •Failure to respond to a combination treatment of adalimumab and methotrexate (must have taken combination at least 3 months) or loss of a satisfactory response to the combination of adalimumab and methotrexate, which was taken for at least 6 months (if currently taking adalimumab must complete 2 weeks without it prior to starting study drug)
- •Negative for hepatitis B and C
- •Negative serum and urine pregnancy tests before starting study
- •currently taking (stable dose) 15 mg methotrexate weekly for at least 8 weeks/has been taking methotrexate for at least 12 weeks total - lower dose of 10 mg per week is permitted with documented intolerability
- •Normal chest X-ray within 3 months
- •Negative testing for tuberculosis (TB)
排除标准
- •Class IV RA (wheel-chair or bed-bound)
- •Significant concurrent medical conditions, including: (uncontrolled type 1 diabetes, poorly controlled type 2 diabetes, symptomatic heart failure, myocardial infarction in past year, history of unstable angina within past year, uncontrolled hypertension, severe chronic pulmonary disease, major chronic inflammatory or connective tissue disease other than RA, Multiple sclerosis, active malignancy, or history of cancer, alcoholic hepatitis or history of alcoholic liver disease)
- •Other inclusion/exclusion criteria may apply
研究组 & 干预措施
Etanercept
Participants received etanercept 50 mg administered subcutaneously once a week with methotrexate for 24 weeks
干预措施: Methotrexate (Drug)
Etanercept
Participants received etanercept 50 mg administered subcutaneously once a week with methotrexate for 24 weeks
干预措施: Etanercept (Biological)
结局指标
主要结局
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12
时间窗: Baseline and Week 12
A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.
次要结局
- Percentage of Participants With an ACR 20 Response at Week 12 by Anti-adalimumab Antibody Subgroup(Baseline and Week 12)
- Percentage of Participants With DAS 28-CRP < 3.2(Weeks 12 and 24)
- Percentage of Participants With an ACR 20 Response at Week 12 by Response Failure Type Subgroup(Baseline and Week 12)
- Percentage of Participants With an ACR 20 Response at Week 24(Baseline and Week 24)
- Percentage of Participants With an ACR 50 Response at Weeks 12 and 24(Baseline and Weeks 12 and 24)
- Percentage of Participants With an ACR 70 Response at Weeks 12 and 24(Baseline and Weeks 12 and 24)
- Change From Baseline in Disease Activity Score 28-C-Reactive Protein (DAS28-CRP)(Baseline and weeks 12 and 24)
- Percentage of Participants With DAS28-CRP Improvement of ≥ 1.2 Units From Baseline(Baseline and weeks 12 and 24)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)(Baseline and weeks 12 and 24)
- Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 12(Baseline and Week 12)
- Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 24(Baseline and Week 24)
- Work Productivity and Activity Impairment (WPAI)(Baseline, week 12 and week 24)